FDA 510(k) Application Details - K171728

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K171728
Device Name	Implant, Endosseous, Root-Form
Applicant	Sterngold Dental, LLC 23 Frank Mossberg Drive Attleboro, MA 02703 US Other 510(k) Applications for this Company
Contact	Maria Rao Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	DZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/12/2017
Decision Date	09/28/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review